Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA)

Christoph U. Herborn*, Elmar Honold, Michael Wolf, Jörn Kemper, Sonja Kinner, Gerhard Adam, Jörg Barkhausen

*Corresponding author for this work
79 Citations (Scopus)


OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.

Original languageEnglish
JournalInvestigative Radiology
Issue number1
Pages (from-to)58-62
Number of pages5
Publication statusPublished - 01.01.2007


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